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Results For "United-States"

840 News Found

US court lifts launch restrictions on Sun Pharma's autoimmune drug
News | April 11, 2025

US court lifts launch restrictions on Sun Pharma's autoimmune drug

Sun Pharma has been involved in a patent infringement case with Incyte Corporation over LEQSELVI


Sumitomo Chemical establishes a CRO for Oligonucleotide CDMO business in US
News | April 07, 2025

Sumitomo Chemical establishes a CRO for Oligonucleotide CDMO business in US

Sumitomo Chemical began its nucleic acid drug substance contract manufacturing business in 2013


Gland Pharma receives approval for Acetaminophen Injection
Drug Approval | April 04, 2025

Gland Pharma receives approval for Acetaminophen Injection

The company expects to launch this product through its marketing partner in the near future


OneSource Specialty Pharma updates on cGMP inspection by USFDA
Drug Approval | April 01, 2025

OneSource Specialty Pharma updates on cGMP inspection by USFDA

The inspection has concluded with four observations


Merck seeks FDA approval for subcutaneous pembrolizumab
Drug Approval | March 29, 2025

Merck seeks FDA approval for subcutaneous pembrolizumab

Subcutaneous pembrolizumab administered every six weeks with a median injection time of two minutes, in combination with chemotherapy, shows consistent results across reported efficacy and safety endpoints compared to IV KEYTRUDA in combination with chemotherapy


European Commission approves Merck’s Capvaxive for prevention of invasive pneumococcal disease
Drug Approval | March 27, 2025

European Commission approves Merck’s Capvaxive for prevention of invasive pneumococcal disease

EC decision marks the fourth approval for CAPVAXIVE for pneumococcal vaccination in adults


Merck inks $200 million deal for Hengrui's midstage heart disease drug
News | March 26, 2025

Merck inks $200 million deal for Hengrui's midstage heart disease drug

Hengrui Pharma has granted Merck exclusive rights to develop, manufacture and commercialize HRS-5346 worldwide, excluding Greater China region


Briefs: Alembic Pharmaceuticals and Shelter Pharma
News | March 24, 2025

Briefs: Alembic Pharmaceuticals and Shelter Pharma

Alembic Pharmaceuticals successfully completes USFDA inspection for API-III facility


J&J to break ground on new biologics facility in North Carolina
News | March 24, 2025

J&J to break ground on new biologics facility in North Carolina

New facility will support plans to advance J&J’s portfolio and pipeline of transformational medicines for cancer, immune-mediated and neurological diseases


Glenmark receives ANDA approval for Olopatadine Hydrochloride ophthalmic solution USP, 0.2%
Drug Approval | March 21, 2025

Glenmark receives ANDA approval for Olopatadine Hydrochloride ophthalmic solution USP, 0.2%

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC), will be distributed in the US by Glenmark Therapeutics, USA.